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zanidatamab

Ziihera · ATC code L01FD07

Key facts
Active substance
zanidatamab
ATC code
L01FD07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Ziihera 300 mg powder for concentrate for solution for infusion.
Marketing authorisation holder
Jazz Pharmaceuticals Ireland Limited
Information as of
2026-10-29

Key facts

Zanidatamab (Ziihera) is a bispecific HER2-directed antibody used to treat advanced HER2-positive biliary tract cancer after prior therapy.

What it is used for

  • Monotherapy for adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one line of systemic therapy.
  • HER2 status (IHC 3 +) must be documented with a validated test.

Dosing

  • 20 mg/kg as an intravenous infusion every 2 weeks (every 14 days) until disease progression or unacceptable toxicity.
  • Premedication with a corticosteroid, antihistamine and antipyretic 30 to 60 minutes before each infusion.
  • For LVEF decreases withhold or discontinue; for infusion-related reactions reduce the infusion rate by 50% or interrupt – see the full text.
  • Administered by a qualified healthcare professional with resuscitation equipment available.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Embryo-foetal toxicity: pregnancy test before starting; with other HER2-directed antibodies oligohydramnios with pulmonary hypoplasia, skeletal abnormalities and neonatal death occurred.
  • Left ventricular dysfunction: assess LVEF before starting and at regular intervals.
  • Infusion-related reactions; premedication is required.

Side effects

  • Most common (pooled data): diarrhoea (48.5%), infusion-related reaction (30.5%), fatigue (26.2%), anaemia (21.9%) and rash (21.5%).
  • Serious adverse reactions in 8.2% of patients, most often diarrhoea (1.7%) and fatigue (1.3%).
  • In BTC (Study 203) also abdominal pain (26.4%).

Interactions

  • No dedicated clinical interaction studies; no impact on cytochrome P450 enzymes is expected.

Pregnancy and breastfeeding

  • May cause foetal harm; effective contraception during treatment and for 4 months after the last dose.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ZiiheraJazz Pharmaceuticals Ireland Limited · EMEA/H/C/006380

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Ziihera
Liechtenstein
Ziihera
Norway
Ziihera

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Ziihera – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/ziihera-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.